FDA Trasylol Failure Could Have Killed Thousands, Researcher Says

Trasylol, a defective drug manufactured by Bayer AG, may have killed 22,000 people before it was pulled from the market last year.Â Trasylol was withdrawn in November at the request of the Food & Drug Administration (FDA) after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients. But a researcher who presented a Trasylol study to the FDA in 2006 told the TV program â€œ60 Minutesâ€ that thousands of lives would have been saved if the FDA had acted sooner.

Trasylol is a drug used to prevent bleeding during heart bypass surgery, and before it was removed from the market, about a third of all bypass patients had received Trasylol.Â In September 2006, Dr. Dennis Mangano presented a study he authored to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death.Â Â Mangano told â€œ60 Minutesâ€ the he believes Trasylol should have been taken off the market when he published his study in 2006. Between the studyâ€™s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” Mangano. “As I calculated, 22,000 lives could have been saved. Itâ€™s about a 1,000 lives per month.â€

Bayer executives attended Manganoâ€™s presentation in order to defend Trasylol.Â What they did not tell the FDA was that their own Trasylol study, known as the I3 drug report, confirmed Manganoâ€™s findings.Â Â That study, which analyzed a database of hospital patients treated with the drug, suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. Bayer claims that this was an oversight, as the companyâ€™s management was not informed of the report until after the safety review.

The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told â€œ60 Minutesâ€ that he would have voted to remove Trasylol from the market if he had known about Bayerâ€™s study. He also took issue with Bayer’s failure to disclose it. “I thought it was unusual. I thought it was truly inappropriate,”

But even after learning of the I3 drug report, the FDA allowed Trasylol to remain on the market.Â In December 2006, the FDA updated the Trasylol label to include a black box warning – the agencyâ€™s strictest safety notice – stating that the drug placed patients at a high risk of kidney failure. Then in September 2007, even while agreeing with the assessment that Trasylol had a high risk of causing fatal side-effects, an FDA advisory panel voted that Trasylol should stay on the market.

It wasnâ€™t until November 2007, when the Canadian Data Safety Monitoring Board had stopped a Trasylol trial – known as the BART clinical study – after a data analysis indicated that the 30-day mortality risk in the studyâ€™s Trasylol patients was nearing â€œstatistical significanceâ€. While the patients in the Trasylol clinical trial did experience less serious bleeding, there were more deaths due to hemorrhage in the Trasylol group.Â Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US at the FDAâ€™s request.

But Bayer still hasnâ€™t given up on Trasylol.Â Â According to â€œ60 Minutesâ€, the company is still defending Trasylol.Â Bayer sent a letter to â€œ60 Minutesâ€ claiming that â€œthe available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.” Â According to the program, Bayer plans to assess whether Trasylol can be remarketed after further research.